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| Name | Class |
|---|---|
| Arizona Biomedical Research Commission (ABRC) | OTHER |
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This pilot study will use an unmasked, parallel group, randomized design. Thirty adult overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for biomarkers, inflammatory markers, and other assessments will be done.
The primary aim of this pilot study is to recruit and retain obese adults with mild-moderate persistent asthma for a study protocol that includes exercise at a moderate intensity level in a home-based setting. The investigators primary hypothesis is that compared to no intervention, 12-weeks of moderate intensity aerobic exercise will attenuate serum levels of adipokines (leptin, adiponectin), and other pro-inflammatory markers. The investigators will also analyze the effect of the intervention on fitness levels, pulmonary function, asthma symptoms, asthma control, and asthma-related quality of life.
Given that this is a proof of concept/feasibility study, there is no primary outcome measure. The following measures will be assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Control group | |
| Home-based Aerobic Exercise | Experimental | Participants will be prescribed weekly exercise goals starting with 75 minutes a week (e.g., 15 minutes per day, 5 days a week) and progressed to 200 minutes a week (e.g., 40 minutes per day, 5 days a week) by week 12. Exercise will consist of participant preference of mobility exercises, most likely walking. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Aerobic Exercise | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Obesity related biomarkers | Obesity markers will be evaluated in peripheral blood: Leptin and adiponectin, two adipokines that have been previously implicated in the link between asthma and obesity will be measured in peripheral blood via ELISA | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) |
| Asthma symptoms | Asthma symptoms will be measured with the Asthma Symptom Utility Index (ASUI) | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) |
| Lung function | Lung function will be evaluated via spirometry according to ATS guidelines. | change from Visit 1 (baseline) and Visit 2 (end of study - 12 weeks later) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chrstian Bime, MD | University of Arizona, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona and the Tucson Unified School District | Tucson | Arizona | 85724 | United States |
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